FDA 510(k) Application Details - K171954

Device Classification Name	More FDA Info for this Device
510(K) Number	K171954
Device Name	ClearLine IV
Applicant	ClearLine MD 300 TradeCenter, Suite 5400 Woburn, MA 01801 US Other 510(k) Applications for this Company
Contact	Rick Romeo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2017
Decision Date	01/25/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review